Covid-19 Real-Time Fluorescence Pcr Detection Kit 50T/Box 100T/Box
Product Description
REAGEN This kit is a full-component lyophilized fluorescent PCR
reagent for patients with suspected cases of pneumonia, suspected
aggregation cases of COVID-19 infection, and other patients who
need to undergo clinical diagnosis of new coronavirus infection.
The COVID-19 ORF1ab and N genes were specifically tested.
Detection Principle
REAGEN The COVID-19 nucleic acid detection kit is based on reverse
transcription PCR combined with fluorescent probe amplification
detection technology. Fluorescent labeling of specific fluorescent
probes. 5'is labeled with a fluorescent reporter group and 3'is
labeled with a fluorescent quencher group. Before amplification,
the fluorescent signal of the reporter group is absorbed by the
quencher group and cannot excite the fluorescent signal; during the
PCR amplification process, Taq polymerase The 5'-3' exonuclease
activity cuts off the fluorescent group of the probe, separates the
fluorescent reporter group and the fluorescent quencher group,
enables the fluorescence monitoring system to receive the
fluorescence signal, and records the increase of the fluorescence
level by the fluorescence PCR instrument .
Kit Contents, Storage and Shelf Life
REAGEN Table1:COVID-19 Real-Time Fluorescence PCR Detection Kit
(lyophilized)
| Component | Amount |
| RT-PCR Mix | 1 bottle |
| Positive control (lyophilized powder) | 1 tube |
| Negative control | 1 tube |
| Manual | 1 |
Note: Components to be prepared by the customer and not provided in
this kit: RNA nucleic acid
extraction kit
The kit is stored at 25 ±5℃ before use, and the validity period is
12 months.
Suggestion: After adding ribozyme-free water to dissolve the RT-PCR
Mix, the reaction solution should be divided into PCR reaction
tubes according to a single portion of the reaction system and
stored at -20℃ to avoid repeated freezing and thawing of the
reagents and affecting the quality of the reagents.
Product Performance Index
a) Amplification efficiency and detection limit
The following results was obtained with Company Standard Materials,
quantified with "COVID-19 RNAtranscribed in vitro Reference
Material" from Shanghai Institute of Measurement and Testing
Technology,NCRM Code: GBW(E) 091112, Certification Series No:
H2003264, Batch Number: 200306, Certificate Date:202003. Period of
validity: 202004.
Product 1 N gene detection limit is 18 copies/reaction, with
R²=0.999 and amplification efficiency=97%.
b) Clinical Validation
Clinical validation was carried out at the PLA Central Division
General Hospital in Wuhan, China withpreviously tested positive RNA
samples using Sansure Biotech's COVID-19 diagnostic kit.
Comparison of Testing Results between REAGEN® Freeze-Dried
Real-Time RT-PCR Detection Kit for COVID-19 and Sansure Biotech
Novel Coronavirus (COVID-19) Nucleic Acid Diagnostic Kit in 39
Clinical Samples.
| Sansure Biotech (N+RNAse P) |
| Positive (CT<35) | Suspected (Grey Range,35<CT≤40) | Negative (CT>40 or NA) | Total |
REAGEN (N+RNAse P) | Positive (CT<35) | 18 | 6 | 0 | 24 |
| Suspected(Grey Range,35<CT<40) | 0 | 10 | 0 | 10 |
| Negative (CT>40 or NA) | 1 | 4 | 0 | 5 |
| Total | 19 | 20 | 0 | 39 |
The results indicate that 87% (34/39) of the positive samples
detected by Sansure Biotech's kits can bedetected with our product,
and among the confirmed positive samples, there were more samples
in thegrey range with Sansure Biotech's kit (20) than with ours
(10). If fresh samples were used in a parallelexperiment, we
anticipate that our product should have a similar or better
performance and detectionrate.
